Status:
NOT_YET_RECRUITING
Evaluation of the Clinical Efficacy and Feasibility of Digital Foot Care Intervention Strategies With Different Intensities in the Prevention of Diabetic Foot Ulcers.
Lead Sponsor:
First Affiliated Hospital of Wenzhou Medical University
Conditions:
Diabetic Foot Ulcers (DFUs)
Eligibility:
All Genders
50-80 years
Phase:
NA
Brief Summary
For people with diabetes who are at risk of foot ulcers, this study compares three digital foot care strategies (with different levels of intensity) to see which one is more effective at preventing ul...
Eligibility Criteria
Inclusion
- Age ≥ 50 years but \< 80 years;
- Assessed to meet the criteria for the high-risk population for diabetic foot as defined by the International Working Group on the Diabetic Foot (IWGDF) (risk level 3);
- Capable of using a smartphone to take photos and operate apps, or able to do so after simple training;
- Willing to participate in the study and sign an informed consent form.
Exclusion
- Currently has an open foot wound or an unresolved foot ulcer;
- History of major lower limb amputation above the ankle joint;
- Pregnancy or breastfeeding;
- Currently suffering from poorly controlled malignant tumors;
- Receiving glucocorticoid or immunosuppressive therapy;
- Diagnosed with vascular occlusive vasculitis;
- Presence of foot fracture;
- Significant visual impairment affecting image acquisition or operation;
- Other conditions deemed inappropriate for participation in this study by the research team.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2028
Estimated Enrollment :
1512 Patients enrolled
Trial Details
Trial ID
NCT07185048
Start Date
October 1 2025
End Date
September 1 2028
Last Update
September 22 2025
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